भारत सरकार | Government of India                                                                                                                   Font: Website In - Hindi Language

   National Emblem


National Institute of Biologicals

(राष्ट्रीय जैविक संस्थान)

Ministry of Health & Family Welfare, Government of India

(स्वास्थ्य एवं परिवार कल्याण मंत्रालय,भारत सरकार)

 


Nib Logo



  1. SRRD has been functional as an independent unit since 2008. It is one of the important functionaries of the institute. The Unit is main interface between NIB and its stakeholders for all the products that are received in the institute. Biologicals samples of various categories for QC testing are forwarded to NIB from the Drug regulatory authorities of the country as part of mandatory submission of Performance evaluation report required as per regulatory guidelines. Besides, samples are also accepted from several government medical organizations (medical supplies), Drug Inspectors (Survey and Samples forwarded under the Drugs & Cosmetics Act).

     

    A. Sample submission requirements:

    I. Essential Documents:

    a. Forwarding Letter from Drug Regulatory Authority or any other statutory authority of the country which has been marked to NIB for testing/evaluation purpose.

    b.  Copy of Import License/Test License issued by Govt. of India

    i.  Form -11 (Copy of Import License for Testing purpose)

    ii.  Form -10 (Copy of Import License for Commercial purpose)

    iii. Form MD-15 (Copy of License to Import Medical Device)

    iv. Form MD-17 (License to Import Medical Devices for the purpose of Evaluation)

    v. Form MD-13 (License to Manufacture Medical Devices for the purpose of Testing)

    c.  Copy of Manufacturing License Issued by Govt. of India (In case of Indigenous Product) Form         25/28/29

    d.  Certificate of Analysis from Manufacturer in respect of the lot submitted for evaluation. 

    e. Batch Release Certificate (BRC) from Manufacturer/NCA/NCL of the Country of origin for the lot       submitted for evaluation.

    f.  Pack insert and label Claim of the Product

     

    II.  Product Specific requirements

    a) Blood Products Lab- Plasma Based products

    1. Batch Release from the country of origin for imported samples 

    2. Certification of analysis with name of pharmacopoeia complied

     

    b)  Biochemical kit lab

    b1) Blood Glucose Test Strips:

    Quantity of Sample: A total of 1200 test strips for testing by laboratory & 1200 test strips as retained sample by the SRRD unit.

    Sample Accessories required:

    (i) Compatible 10 Nos. of Glucometers as a closed system

    (ii) Normal Control Solution (3 mL x 3 Vials)

                    (iii) Pathological Control Solution (3 mL x 3 Vials)

     

    b2.1) Fully automated analyzer based Glucose Reagent- Open Ended Chemistry:

    Quantity of Sample: 500 mL of Glucose reagent (sufficient to perform 1000 tests) for testing by laboratory & 500 mL of Glucose reagent as retained sample by the SRRD unit.

    Sample Accessories required:

    (i) Calibrator

    (ii) Normal Control

    (iii) Pathological Control

    (iv) Machine protocol

    Materials at (i), (ii) and (iii) to be submitted in quantity enough to last over 25 days of QC protocol execution – keeping in view the shelf life of the respective preparations.

     

    b2.2) Fully automated analyzer based Glucose Reagent- Closed Chemistry System:

    Quantity of Sample: Glucose Reagents/ Test Cartridges/ Modules/ Slides/ Cassettes/ Packs/ Bottles/ Dry-chemistry Cards should be in sufficient quantity to be used for 25 working days for QC protocol execution/ 1000 tests (whichever applicable), irrespective of number of tests possible from each unit/pack/cartridge, keeping in view the on-board shelf life of the respective preparations & 1000 tests to be retained by SRRD unit.

    Sample Accessories required:

    (i) Temporary installation of the Automated Analyzer

    (ii) ‘Calibrator’ preparation

    (iii) ‘Normal’ control preparation

    (iv) ‘Pathological’ control preparation

     (v) Equipment related consumables- sample cups/ printer paper/ maintenance reagents/ solutions.

    (vi) Service/ technological/ training support with respect to the use of the equipment.

    Materials at (ii), (iii), (iv) and (v) to be submitted in quantity enough to last over 25 days of QC protocol execution – keeping in view the on-board shelf life of the respective preparations.

     

    b3) Glucometer Device:

    Quantity of Sample: Glucometer Devices 10 Nos. required for testing by laboratory and 2 Nos. shall be kept for taking care of exigencies as malfunction etc. to be retained in SRRD Unit.

    Sample Accessories required:

    (i)  Specific Blood Glucose Test Strips as accessory 1200 Strips

    (ii) Level 1 (Normal) Control solution  3ml x 3 vials per model

                    (iii) Level 2 (Pathological) Control Solution 3ml x 3 vials per model.

     

     

    B. Testing fee requirements

     

    Testing Fee Details click

     

     Payment modes

    1. FOR PAYMENT/DEPOSIT OF TESTING FEE THOUGH BANK TRANSFER

     

    NAME OF BANK  :  BANK OF BARODA, SECTOR-29, NOIDA (U.P.) 

    NAME OF ACCOUNT  :  NATIONAL INSTITUTE OF BIOLOGICALS 

    S.B. ACCOUNT  :  26290100001774 

    IFSC CODE  :   BARB0NOIDAX 

    SWIFT CODE  :   BARBINBBNOI

    MICR CODE NO.  :   110012066

    PAN -AAATN5228R 

    GSTIN -09AAATN5228R1ZX 

    ST No.-AAATN5228RST001 

    TIN -09466201769

     

    2. Net banking http://www.nib.gov.in/testing_fee.html

     

    Note:

     

    a) TESTING FEES IS REQUIRED TO BE SUBMITTED IN ADVANCE ALONG WITH THE RESPECTIVE BATCH SENT TO THE INSTITUTE FOR TESTING 

    b) Testing Fees once submitted at NIB for Samples forwarded through Zonal / Sub-zonal/ Port Offices of CDSCO which can be tested at NIB cannot be refunded. 

    c) Testing Fees submitted at NIB for Samples which cannot be tested at NIB can be refunded or adjusted against other samples within a month of submission of testing fee. 

    d) Testing Fees submitted Online should also be intimated to the Institute through email (1) srrd@nib.gov.in (2) sksharma@nib.gov.in 

     

    C. Sample forwarded under the Drugs & Cosmetics Act

    Govt. Analysts under schedule C1 as per the Gazette notification are notified for the below mention class of drugs. Govt_analyst.html

     

    D. Documentation and Archiving

    All documents and records are kept in compliance to ISO: 17025. 

     

    E. Surveillance:

    Complete Unit is under CCTV Surveillance for necessary security and maintenance of samples and records. 

     

    F.Customer feedback:  is always acknowledged. Submission of feedback should be marked at srrd@nib.gov.in. Further a Suggestions / Complaints / Feedback Register has also being placed in the Unit for necessary redressal.

     

     

     

     
updates

 
REVISED RATES OF TESTING CHARGES / FEE APPROVED AND APPLICABLE W.E.F. 01.06.2016new

 

Turnaround time for testing new

 

Disclaimer          copyright                 Hyperlink Policy                       Terms & Conditions                   Privacy Policy                    accessibility Policy                     WebInfoManager                          Feedback      


This website belongs to "National Institute of Biologicals", Ministry of Health & Family Welfare, Govt. of India.
   Site Designed, Developed and Hosted by National Informatics Centre Services Inc.